AbbVie’s EMRELIS™ Receives FDA Accelerated Approval for Advanced Non-Small Cell Lung Cancer With High c-Met Overexpression
Thursday, May 15, 2025
AbbVie has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for EMRELIS™ (telisotuzumab vedotin-tllv) to treat adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) characterised by high c-Met protein overexpression.
EMRELIS combines a c-Met-binding antibody with a cleavable linker and the cytotoxic agent monomethyl auristatin E (MMAE). The c-Met protein, a receptor tyrosine kinase, is linked to tumour progression and poor outcomes in NSCLC when overexpressed.
NSCLC accounts for approximately 85% of lung cancer cases globally. Among patients with advanced EGFR wild-type, non-squamous NSCLC, around 25% show c-Met overexpression. Approximately half of these patients are categorised as having high c-Met overexpression, defined by ≥50% of tumour cells showing strong (3+) staining via an FDA-approved test.
This approval applies to patients who have previously received systemic therapy and is based on overall response rate (ORR) and duration of response (DOR). Continued approval may depend on confirmation of clinical benefit in ongoing studies.
This decision is based on overall response rate (ORR) and duration of response (DOR), with continued approval dependent on confirmation of clinical benefit in ongoing trials. EMRELIS is the first approved c-Met-directed antibody-drug conjugate (ADC) for this patient group. ADCs are engineered to identify and bind to specific proteins like c-Met and deliver a cancer-killing payload directly to affected cells.
EMRELIS received Breakthrough Therapy Designation from the FDA in December 2021. A Phase 3 global confirmatory trial, TeliMET NSCLC-01, is ongoing to further evaluate its safety and efficacy.
The FDA has also approved the VENTANA® MET (SP44) RxDx Assay developed by Roche. This is currently the only companion diagnostic test available to identify NSCLC patients eligible for EMRELIS treatment, using either recent or archived tumour tissue.
Source: abbvie.com
